Comparing Online Pulmonary Rehabilitation 'myPR' Versus Conventional Pulmonary Rehabilitation for Patients With COPD
NCT ID: NCT02706613
Last Updated: 2016-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2015-07-31
2016-06-30
Brief Summary
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Currently, the provision of PR in the NHS is limited to group sessions run over an established protocol of 6 weeks. Whilst this has been demonstrated to improve exercise capacity, access to PR classes can be problematic for some patients. Also, staff and facility resources limit delivering the programme at scale. An online PR programme developed by my mhealth known as 'myPR', in consultation with patients and physiotherapy experts, offers an alternative provision of this important intervention.
The study aims to compare this online PR programme to conventional face-to-face PR as currently delivered by the NHS. The study aims to recruit 106 patients referred for PR from Portsmouth Hospital and local Participant Identification Centres.They will then be assessed for suitability onto PR, consented and randomised onto an arm of the study. 36 will undertake a conventional PR programme as reflected in the NHS, and 70 the online PR programme known as 'myPR'. Pre and post programme measurements including walking distance and quality of life questionnaires will then be compared between each arm of the trial, to ensure that the online PR is not inferior to the conventional face-to-face PR.
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Detailed Description
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If a participant decides they would like to take part and contacts the respiratory research team or have been contacted by the team, an initial appointment will be arranged. This will take part at the participants home, GP surgery or Queen Alexandra Hospital depending on the patients choice. After obtaining consent, suitability for inclusion onto pulmonary rehabilitation will be assessed. A full medical history (including confirmation of diagnosis, COPD severity, smoking history, medications and current activity) along with blood pressure will be taken to assess for any exclusion criteria. The timed "Up and Go" Test will also be performed to assess safety of mobility and exercising. This is to ensure it is safe for the participant to exercise independently. If a participant does not meet the inclusion criteria, they will be referred back to their GP with the reason they were not suitable for PR. It is explained to the participant that they can withdraw from the study at any point and that this will not affect their care. If a participant decides they do not wish to be included onto the study they will be referred to the conventional NHS PR programme. If a participant is suitable for PR and is willing to participate, further screening is undertaken. This can take place immediately if this initial appointment is carried out at QAH, or a further appointment will be arranged at QAH will be arranged.
The next stage of the assessment (this may be a further appointment (visit 2) if the initial assessment was not carried out a QAH) will take place at Queen Alexandra Hospital where the space is available to carry out the assessments. Transport can be provided to this venue if required. Consent will first be obtained and participants will then complete the first of two walking test for 6 minutes to measure how far they can walk, known as the six-minute walking test . Oxygen levels will be measured using a probe that fits on the finger and if significant oxygen desaturation is noted, the participant will be withdrawn from the study and referred onto the local oxygen assessment centre. The participant will be asked to fill out four health- related questionnaires and they will then repeat the six minute walking test and the best of the two tests will be recorded.
If the participant is suitable to undertake a PR programme they will then be randomised to either receive the online PR 'my PR', or the conventional face-to-face PR. Randomisation will be undertaken by an online randomisation system hosted by my mhealth.
Participants randomised to receive the conventional PR will be given 12 visit dates (twice a week for six weeks) at the PR venue where the face-to-face sessions will take place. This attendance length and frequency is standard for PR. The components of the PR programme will include an exercise programme, including a warm-up and cool- down programme. Education sessions will also be provided and includes anatomy of the lungs and what is COPD, anxiety and depression, claiming benefits, self management, managing breathlessness, medications and treatments, managing exacerbations of COPD and chest infections, clearing sputum and the Active Cycle of Breathing Technique, nutrition, pacing, smoking cessation and advice on travel with COPD. Participants on the face to face arm will also be instructed to carry out the pulmonary rehabilitation exercises an additional three times a week at home. An exercise leaflet used in the PR classes will be given to be filled out at home.
Those randomised to receive the online programme will be loaned a computer/tablet for the six-week duration, given log-in details and a password, and instructions to begin the programme at home. A further visit to these participants home may need to be arranged to ensure that the Internet connection is suitable. If the internet connection is unsuitable, the participant will be withdrawn from the study and referred to the NHS PR. The online programme mirrors the conventional face-to-face PR programme and the exercise and educational components are given by means of instructional videos. Participants will be instructed to exercise five times a week. Participants in the online arm will receive during the PR course telephone contact to record any adverse or serious adverse events. They will be contacted twice during the first 2 weeks, then weekly for the remaining 5 weeks.
After completing the 6- week online PR or the 6- week conventional PR, participants will have their final visit arranged which will take place at the Queen Alexandra Hospital. The pre-PR measurements including the two 6-minute walking tests and quality of life questionnaires will be repeated, and results collected. These measurements will be statistically analysed for comparison between the two arms of the study to ensure the online PR is not inferior to face-to-face PR.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Face to Face Pulmonary Rehabilitaton
6 week incremental pulmonary rehabilitation (PR) programme. Participants will attend 12 sessions over the 6 week period. The components of the PR programme will include an exercise programme. Education sessions will also be provided and include anatomy of the lungs and what is COPD, anxiety and depression, self management, managing breathlessness, medications and treatments, managing exacerbations of COPD and chest infections, clearing sputum and the Active Cycle of Breathing Technique, nutrition, pacing, smoking cessation. Participants on the face to face arm will also be instructed to carry out the pulmonary rehabilitation exercises an additional three times a week at home.
Face to Face Pulmonary Rehabilitaton
6 week face to face, incremental exercise and education programme for people with COPD
Online Pulmonary Rehabilitation
Those randomised to receive the online programme will be given log-in details and a password, and instructions to begin the 6 week programme at home. The online programme mirrors the conventional face-to-face PR programme and the exercise and educational components are given by means of instructional videos. Participants will be instructed to exercise five times a week. Participants in the online arm will receive during the PR course telephone contact to record any adverse or serious adverse events.
Online Pulmonary Rehab
6 week online, incremental exercise and education programme for people with COPD
Interventions
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Face to Face Pulmonary Rehabilitaton
6 week face to face, incremental exercise and education programme for people with COPD
Online Pulmonary Rehab
6 week online, incremental exercise and education programme for people with COPD
Eligibility Criteria
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Inclusion Criteria
2. A diagnosis of COPD defined as per the NICE COPD guidelines with an MRC score of 2 or greater or appropriately symptomatic patients.
3. Male or female volunteers aged 40+ with a diagnosis of COPD referred for pulmonary rehabilitation
4. Access to the internet and ability to operate a web platform
Exclusion Criteria
2. Patients who have already undertaken a pulmonary rehabilitation programme within the last 6 months
3. Patients who have another respiratory disease as their main complaint, such as asthma, bronchiectasis, lung cancer, tuberculosis or any other significant respiratory disease.
4. Uncontrolled hypertension
5. Unstable cardiovascular disease that would make pulmonary rehabilitation exercise unsafe or prevent programme participation
6. Patients who are unable to walk or whose ability to walk safely and independently is significantly impaired due to non-respiratory related conditions and/or cognitive impairment
7. Patients who are unable to read, or use an internet enabled device or do not have access to the internet at home
8. A timed 'Up and Go' test greater than 14 seconds
40 Years
ALL
No
Sponsors
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Portsmouth Hospitals NHS Trust
OTHER_GOV
my mhealth Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Ben Green, Dr
Role: PRINCIPAL_INVESTIGATOR
Portsmouth Hospitals NHS Trust
Locations
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Portsmouth Hospital NHS Trust
Portsmouth, Hampshire, United Kingdom
Countries
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References
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Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
Sewell L, Singh SJ, Williams JE, Collier R, Morgan MD. [Can individualized rehabilitation improve functional independence in elderly patients with COPD?]. Rev Port Pneumol. 2005 Nov-Dec;11(6):593-6. No abstract available. Portuguese.
Garcia-Aymerich J, Lange P, Benet M, Schnohr P, Anto JM. Regular physical activity reduces hospital admission and mortality in chronic obstructive pulmonary disease: a population based cohort study. Thorax. 2006 Sep;61(9):772-8. doi: 10.1136/thx.2006.060145. Epub 2006 May 31.
ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
Borg G. Perceived exertion as an indicator of somatic stress. Scand J Rehabil Med. 1970;2(2):92-8. No abstract available.
Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
Snaith RP, Zigmond AS. The hospital anxiety and depression scale. Br Med J (Clin Res Ed). 1986 Feb 1;292(6516):344. doi: 10.1136/bmj.292.6516.344. No abstract available.
Redelmeier DA, Bayoumi AM, Goldstein RS, Guyatt GH. Interpreting small differences in functional status: the Six Minute Walk test in chronic lung disease patients. Am J Respir Crit Care Med. 1997 Apr;155(4):1278-82. doi: 10.1164/ajrccm.155.4.9105067.
Troosters T, Gosselink R, Decramer M. Six minute walking distance in healthy elderly subjects. Eur Respir J. 1999 Aug;14(2):270-4. doi: 10.1034/j.1399-3003.1999.14b06.x.
Kon SS, Canavan JL, Jones SE, Nolan CM, Clark AL, Dickson MJ, Haselden BM, Polkey MI, Man WD. Minimum clinically important difference for the COPD Assessment Test: a prospective analysis. Lancet Respir Med. 2014 Mar;2(3):195-203. doi: 10.1016/S2213-2600(14)70001-3. Epub 2014 Feb 4.
Cote CG, Casanova C, Marin JM, Lopez MV, Pinto-Plata V, de Oca MM, Dordelly LJ, Nekach H, Celli BR. Validation and comparison of reference equations for the 6-min walk distance test. Eur Respir J. 2008 Mar;31(3):571-8. doi: 10.1183/09031936.00104507. Epub 2007 Nov 7.
Fletcher CM. Standardised questionnaire on respiratory symptoms: a statement prepared and approved by the MRC Committee on the Aetiology of Chronic Bronchitis (MRC breathlessness score). BMJ 1960; 2: 1665.
Jones PW, Quirk FH, Baveystock CM. The St George's Respiratory Questionnaire. Respir Med. 1991 Sep;85 Suppl B:25-31; discussion 33-7. doi: 10.1016/s0954-6111(06)80166-6.
Mesquita R et al. Timed Up and Go test in COPD: Changes over time, validity and responsiveness to pulmonary rehabilitation. ERJ September1, 2014 vol 44 suppl 58 P3037
Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
Related Links
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NICE COPD Guidelines
Other Identifiers
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PHT/2015/069
Identifier Type: -
Identifier Source: org_study_id
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